Contact Sensitization Potential of 828 Ointment

Healthy Volunteers Clinical Trial

Official title:

Evaluation of the Contact Sensitization Potential of 828 Ointment in Normal Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767676
• Other study ID #: 828-101-09-011
• Status: Completed
• Phase: Phase 1
• First received: October 4, 2008
• Last updated: June 26, 2014
• Start date: October 2008
• Est. completion date: November 2008

Study information

• Verified date: June 2014
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Contact sensitization by patch applications.

Description:

Single site study that will evaluate the contact sensitization potential of 828 ointment by repetitive patch applications to the skin of normal, healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

1. SUBJECTS 1.1 SUBJECT POPULATION

Subjects will be normal, healthy volunteers of both genders aged 18 to 65 years.

Inclusion Criteria:

Subjects must satisfy all of the following criteria:

1. Subjects must be ambulatory, 18 to 65 years of age and in reasonably good health (no physical required).

2. Subjects may be of any race or skin type provided their skin pigmentation does not interfere with evaluations.

3. Female subjects must be surgically sterile, post-menopausal or using an acceptable method of birth control.

4. Minor deviations in normal medical history not considered to be clinically significant by the investigator and the sponsor will be permitted.

5. Subjects must refrain from sunbathing, using tanning salons, swimming, or using hot tubs during the entire study.

6. Bathing is permitted but subjects must agree to try and keep the patches as dry as possible.

7. Subjects must read and sign the informed consent statement.

8. All females of child bearing potential must agree to take an entry and exit urine pregnancy test

Exclusion Criteria:

Subjects with any of the following conditions are not eligible for participation:

1. Any systemic disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (i.e., hepatitis, acute or chronic renal insufficiency).

2. Use of a prescribed pain medication, prescribed or over-the-counter anti-inflammatory drugs, immunosuppressive drugs or prescribed antihistamine medication (steroid nose drops and/or eye drops are permitted). Use of any over-the-counter pain medication that is ingested in quantities exceeding label instructions.

3. Subjects who have received an investigational drug or have participated in a Draize type patch test within the past 28 days or who are currently participating in or plan to enter a clinical trial.

4. A history of non-compliance or subjects who are considered potentially unreliable.

5. A history of skin allergies, including known sensitivity or strong reactions to any cosmetics and/or personal care products, topically prepared medical dressings, tapes, or adhesives.

6. A history of clinically significant skin diseases which may contraindicate participation, including psoriasis, active eczema (at the test sites), atopic dermatitis, and active cancer, even if currently controlled through medication.

7. Current use of topical or oral antibiotics.

8. Use of topical medications at the test area 2 weeks prior to enrollment or any body lotions/oils/creams at the test area for 48 hours prior to enrollment and throughout the trial.

9. Female subjects who are pregnant, stop contraceptive measures, expect to become pregnant or who are breast-feeding.

10. Subjects with any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.

11. Subjects with hematological disorders or immunologic disorders (HIV positive, AIDS, and Systemic Lupus Erythematosus).

12. Subjects with any significant organ abnormality or disorders including gastric ulcer/insulin dependent diabetes.

13. Subjects with any clinically significant illness (sought medical attention, fever, took prescription medication) within the 4 weeks prior to study entry.

14. History of asthma, chronic bronchitis or any other bronchospastic condition that requires medication.

15. Anticipated change in the use of a systemic medication during the study that may affect the conduct or outcome of the study. Subjects must be stabilized on these medications for a least one month prior to receiving study drug and continue same regimen throughout the study.

16. Bilateral mastectomy for cancer involving removal of lymph nodes.

17. Treatment of any type of cancer within the last six months.

18. The Investigator may declare any subject ineligible for a sound medical reason.

19. Subjects with allergies/known sensitivities to any of the ingredients of the test article.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• HP828-101
Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.

Locations

Country	Name	City	State
United States	RCTS, Inc.	Irving	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Exhibited a Score Less Than 1.5 on the Jordan-King Scale	To qualify for the claim of a reduced sensitization potential, all subjects completing the study could exhibit a value of no more than 1.5 on the Jordan-King Scale [scale is 0 (no visible reaction) to 5 (severe erythema)]; No statistical analyses were performed.	7 weeks	Yes